The primary endpoint for this study is the clinical response after 12 weeks of treatment, defined as a change in total score from baseline depressive symptoms as measured by the Beck Depression Inventory-Amended (BDI-IA) total score.
ACCORDO is a multicentre, randomised, double-blind, and placebo-controlled study conducted in 12 Italian centres. Subjects are screened by means of the BDI-IA (cut-off 15) and randomised to treatment with rasagiline or placebo for 12 weeks. Subjects have to be on stable treatment with dopaminergic agents at least 4 weeks before baseline, and maintained so during the course of the study. The primary objective is to evaluate whether rasagiline compared to placebo improves depressive symptoms as evaluated by the BDI-IA total score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
121
1 mg/day for 12 weeks; orally
Once daily for 12 weeks; orally
IT010
Cagliari, Italy
IT007
Chieti, Italy
IT004
Genova, Italy
IT005
Lido di Camaiore, Italy
Change from baseline in BDI-IA total score
Time frame: 12 weeks
Evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks in idiopathic Parkinson´s Disease, using a formal neuropsychiatric cognitive test battery; quality of life (PDQ 39); apathy; ADL, motor function
Time frame: 12 weeks
Change in quality of life using the PDQ-39 scale
Time frame: 12 weeks
Change in apathy using the Apathy Scale
Time frame: 12 weeks
Change in ADL and motor function using UPDRS scales part II and III, respectively
Time frame: 12 weeks
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IT003
Messina, Italy
IT012
Milan, Italy
IT001
Naples, Italy
IT011
Roma, Italy
IT008
Rome, Italy
IT015
Torino, Italy
...and 2 more locations